Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years

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The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.

Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) GSK1437173A formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: Within the 30-day (Days 0-29) post-vaccination period ]

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Month 0 up to Month 8 ]

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the period after Month 8 up to the end of the study at Month 14 ]

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) [ Time Frame: From Month 0 until Month 8 ]

Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.

Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) [ Time Frame: During the period after Month 8 up to the end of the study at Month 14 ]

Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.

Number of Subjects With Suspected Cases of Herpes Zoster (HZ) [ Time Frame: From Month 0 until Month 8 ]

A suspected case of HZ was defined as a rash consistent with HZ.

Number of Subjects With Suspected Cases of Herpes Zoster (HZ) [ Time Frame: During the period after Month 8 up to the end of the study at Month 14 ]

A suspected case of HZ is defined as a rash consistent with HZ.

Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges [ Time Frame: At Month 0 ]

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Ages Eligible for Study:

50 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

A male or female 50 years of age or above at the time of the first vaccination;

Written informed consent obtained from the subject;

Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;

If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;

Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.

Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;

Previous vaccination against HZ;

Previous vaccination against varicella;

History of HZ;

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;

Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;

Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period;

Acute disease at the time of enrolment.

Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;

History of or current drug and/or alcohol abuse;

Pregnant or lactating female;

Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.